Trials / Terminated
TerminatedNCT04769453
Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty
Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty, Randomized, Controlled Trial: iTrack (Nova Eye Medical) Compared to Omni (Sight Sciences)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Nova Eye, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multicenter, randomized, single-masked clinical trial to evaluate the effectiveness outcomes of canaloplasty performed as a standalone procedure with the iTrack microcatheter to the Omni surgical system, and to compare the effectiveness of two types of Ophthalmic Viscoelastic Device (OVD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Canaloplasty using the iTrack microcatheter with Healon GV Pro | 360 degree microcatheterization and viscodilation of Schlemm's canal |
| DEVICE | Canaloplasty using the Omni surgical system with Healon GV Pro | 360 degree microcatheterization and viscodilation of Schlemm's canal |
| DEVICE | Canaloplasty using the iTrack microcatheter with Healon Pro | 360 degree microcatheterization and viscodilation of Schlemm's canal |
| DEVICE | Canaloplasty using the Omni surgical system with Healon Pro | 360 degree microcatheterization and viscodilation of Schlemm's canal |
Timeline
- Start date
- 2021-04-29
- Primary completion
- 2023-01-26
- Completion
- 2023-01-26
- First posted
- 2021-02-24
- Last updated
- 2023-03-15
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04769453. Inclusion in this directory is not an endorsement.